NCT07146672 Exploratory Study of Super DC Cell Injection in Preventing Recurrence After Radical Surgery for Tumors
| NCT ID | NCT07146672 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Shanghai Cell Therapy Group Co.,Ltd |
| Condition | Solid Tumor Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2025-07-31 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2025-07-31 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study is a controlled, open-label exploratory clinical trial.
Eligibility Criteria
Inclusion Criteria: * Age 18-80 years old, weight ≥ 40kg; No gender limit； * Subjects with malignant solid tumors diagnosed by histology or cytology and undergoing radical resection surger； * At the beginning of the study (after surgery), there were no lesions, no local recurrence or distant metastasis on the imaging, and no brain metastasis (images within one month before enrollment can be used for screening)； * Subjects in the safety verification stage need to provide immunohistochemical test results with positive expression of Survivin or P53 or MUC1; * ECOG score 0-1 points; * There are sufficient venous channels and no contraindications for peripheral blood mononuclear cell collection surgery; * Organs and bone marrow function well: * a:Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50% evaluated by echocardiography within one month of enrollment; The electrocardiogram is basically normal; * b:Platelets ≥ 90 × 10 \^ 9/L; * c:Hemoglobin ≥ 90g/L (no blood transfusion or erythropoietin dependence within 7 days); * d:Total bilirubin ≤ 2 times the upper limit of normal value; * e:Serum creatinine ≤ 1.5 times the upper limit of normal value; * f:Transaminases (AST, ALT) ≤ 2.5 times the upper limit of normal value (if liver cancer is 5 times the upper limit of normal value); * g:International standardized ratio (INR) or prothrombin time (PT) ≤ 1.5 times the upper limit of normal value; * Able to understand trial requirements and matters, willing to participate in clinical research according to trial requirements Exclusion Criteria: * Positive for HIV antibodies or syphilis antibodies; positive for hepatitis B surface antigen, and positive for hepatitis B core antibody or e antibody with viral DNA copy number above the detection limit or ≥1000 copies/ml; or hepatitis C virus RNA copy number above the detection limit. * Any uncontrollable active infection, coagulation disorder, or any other major disease; * Pregnant or lactating women; * Suffering from active neuroautoimmune or inflammatory diseases, such as any of the following: inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, multiple sclerosis, Sjogren's syndrome, etc., and receiving relevant treatment; Subjects who are still using immunosuppressants for organ transplantation; Or subjects who have been using immunosuppressive drugs such as glucocorticoids for a long time cannot stop at least 4 weeks before enrollment; Severe allergic constitution; * Subjects with existing abnormalities in the central nervous system, such as seizures, cerebral vascular ischemia/bleeding, dementia, cerebellar diseases, or any autoimmune diseases associated with central nervous system involvement; * Major cardiovascular diseases with clinical significance include:
Frequently Asked Questions
Who can join the NCT07146672 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Solid Tumor Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07146672 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07146672 currently recruiting?
Yes, NCT07146672 is actively recruiting participants. Visit ClinicalTrials.gov or contact Shanghai Cell Therapy Group Co.,Ltd to inquire about joining.
Where is the NCT07146672 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07146672 clinical trial?
NCT07146672 is sponsored by Shanghai Cell Therapy Group Co.,Ltd. The trial plans to enroll 12 participants.
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